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Ethics & Regulatory Compliance


All MACRO personnel and investigator clients have completed U. Pittsburgh research ethics training. Many have also completed NIH research ethics training. MACRO has had no research ethics problems for this time period, nor any since its founding.

Regulatory Compliance

For this time period MACRO has had no unanticipated events requiring IRB action or remediation, FDA “for cause” audits, FDA warning letters, nor any other significant regulation violation. MACRO efficiently handles IRB submissions and all other regulatory requirements. Many researchers and coordinators have contacted MACRO for advice on complex regulatory issues such as subject screening, delayed informed consent, and electronic consenting.

Ms. Vera Iouchmanov principally handles regulatory compliance for MACRO. A major project over this reporting time period was successfully creating a system that centralized research billing compliance. This system tracks and confirms that research services are billed properly to research accounts and not to patients or their insurance, and vice versa.

Study monitors have been highly satisfied with MACRO’s work. Select comments are provided below.

  • Ms. Kim Overton, National Trauma Institute, for our assistance with a Department of Defense trauma grant (PI: Dr. Jason Sperry, Surgery and CCM): “I will tell you it (a quick review turn around) really is not that common!  So thank you for the easy review. I am positive it is why the approval came through in 4 days.  Generally it takes 6-8 WEEKS!!  Keep up the great work!”
  • Ms. Tonia Moore, Quintiles, for our assistance with NPSO21 study (short bowel TPN study) (PI: Dr. Stephen O’Keefe, Professor of Medicine Division of Gastroenterology): “I just want to express to you my appreciation for the opportunity to work with your Research Staff. Everyone has been very friendly and accommodating. Particularly, Vera and Patsy who have demonstrated great willingness and helpfulness in “getting the job done”. They are very resourceful and have worked very diligently to meet every data point of this study.”